Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02191072
• Date of registration: 09/07/2014
• Prospective Registration: No
• Primary sponsor: National Taiwan University Hospital
• Public title: Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
• Scientific title: Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
• Date of first enrolment: July 2014
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02191072
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Tsai Tsen-Fang
• Affiliation: Department of Dermatology, National Taiwan University Hospital

• Name: Tsai Tsen-Fang

• Name: Hsien-Yi Chiu, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 20-75 years(2)Documented diagnosis of acute urticaria within 3 years

- Documented diagnosis of acute urticaria within 3 years

- Daily UAS at the beginning of study more than or equal to 4

- At time of enrollment, the symptoms of this episode had persisted longer than 3 days
even under oral/intravenous antihistamines with or without oral corticosteroid
therapy

Exclusion Criteria:

- Weight < 20 kg

- Continuous use of suspected drugs that may induce acute urticaria

- Pregnant woman

- Evidence of parasitic infection defined as having the following three items:Risk
factors for parasitic disease (living in an endemic area, chronic gastrointestinal
(GI) symptoms, travel within the last 6 months to an endemic area and/or chronic
immunosuppression) AND An absolute eosinophil count more than twice the upper limit
of normal AND Evidence of parasitic colonization or infection on stool evaluation for
ova and parasites. Note that stool ova and parasite evaluation will only be conducted
in patients with both risk factors and an eosinophil count more than twice the upper
limit of normal.

- Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or
other skin disease associated with itch

- Treatment with omalizumab within 12 months before screening

- Treatment with any investigational agent within 30 days of screening

- IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day -14

- Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to Day -14

- Patients with current malignancy, history of malignancy, or currently under work-up
for suspected malignancy except non-melanoma skin cancer that has been treated or
excised and is considered resolved

- Hypersensitivity to omalizumab or any component of the formulation

- History of anaphylactic shock

- Presence of clinically significant cardiovascular, neurological, psychiatric,
metabolic or other pathological conditions that could interfere with the
interpretation of the study results and or compromise the safety of the patients

- Medical examination or laboratory findings that suggest the possibility of
decompensation of co-existing conditions for the duration of the study. Any items
that are cause for uncertainty must be reviewed with the Medical Monitor

- Inability to comply with study and follow-up procedures

- Evidence of current drug or alcohol abuse



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Urticaria

Intervention(s)

Drug: omalizumab

Primary Outcome(s)

Change in daily Urticaria Activity Score [Time Frame: D0,1,2,3,4,5,6,7and 1 hour]

Secondary Outcome(s)

Proportion of patient could stop H1-antihistamine treatment [Time Frame: Day 0,3]

Proportion of patient with daily UAS=0 at Day 1, Day 3 [Time Frame: Day 1,3]

The frequency and severity of treatment-emergent AEs and SAEs [Time Frame: 6 weeks follow-up period]

Change from baseline in size of largest hive score [Time Frame: Day 0,1, 3]

Proportion of angioedema-free days [Time Frame: Day 3,4,5,6,7]

Change from baseline in itch severity score [Time Frame: Day 0,1,3]

Secondary ID(s)

201404056MIPC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors